Kornimate/medical-research-clean huggingface dataset:
comparison of dtap-ipv-hep b-prp~t combined vaccine to combact-hib® concomitantly given with engerix b® paediatric and opv

Conditions: Hepatitis B; Polio; Diphtheria; Pertussis; Haemophilus Influenzae Type b

Summary: the purpose of this study is to document the immunological response to the investigational hexavalent vaccine at the 6, 10, and 14 weeks schedule the primary objective is to demonstrate that the hexavalent dtap-ipv-hb-prp\~t combined vaccine does not induce lower immune responses than combact-hib® with engerix b® paediatric and opv in terms of seroprotection rates to diphtheria (d), tetanus (t), polio, hepatitis b (hb), and polyribosyl ribitol phosphate (prp), one month after a 3-dose primary series (6, 10, and 14 weeks) with no hb vaccination at birth. the secondary objectives are: to describe the safety in terms of any adverse events in the first 28 days after each injection and any serious adverse events during the entire trial. to describe immunogenicity after the primary series and prior to and after a booster vaccination.


Eligibility criteria:
inclusion criteria: * 0 to 3 day old infants * mother seronegative for human immunodeficiency virus (hiv) * born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg * apgar score \>7 at 5 or 10 minutes of life * informed consent form signed by a parent or other legal guardian and by an independent witness if the parent or other legal guardian is illiterate * able to attend all scheduled visits and to comply with all trial procedures. exclusion criteria: * current or planned participation in another clinical trial during the entire duration of the present trial * suspected congenital or acquired immunodeficiency * suspected maternal acute seroconversion syndrome to hiv after 24 weeks gestation based on clinical history * chronic illness at a stage that could interfere with trial conduct or completion * blood or blood-derived products received since birth * any planned vaccination (except bacille calmette guérin and trial vaccinations) from birth to 18 weeks of age * oral poliovirus vaccine (opv) administration at birth * known maternal history of hiv, hepatitis b (hb) (hbsag carrier) or hepatitis c seropositivity * thrombocytopenia or bleeding disorder contraindicating intramuscular (im) vaccination * history of seizures * febrile or acute illness on the day of inclusion.

Keywords: hepatitis b polio diphtheria pertussis h. influenzae type b
ondansetron augmentation in treatment-resistant ocd

Conditions: Obsessive Compulsive Disorder

Summary: the aim of this study is to evaluate whether ondansetron augmentation to ssri will improve and ondansetron discontinuation will result in worsening of obsessive compulsive symptoms among obsessive compulsive disorder resistant patients.


Eligibility criteria:
inclusion criteria: * a diagnosis of ocd established by clinical interview with a licensed psychiatrist; * a score of ≥ 24 at the yale brown obsessive compulsive scale * a clinical global inventory score ≥ 4, after over 12 weeks of treatment with an adequate trial of an selective serotonin reuptake inhibitor at a moderate to high dose exclusion criteria: * diagnoses of schizophrenia, schizoaffective disorder, organic mental disorder, bipolar disorder, current substance dependence or abuse, and current major depressive episode preceding the onset of obsessive compulsive disorder * undergoing concomitant behavior therapy * or having significant cardiovascular, hepatic, renal or pulmonary diseases
home tonometry with the i-care tonometer for glaucoma

Conditions: Glaucoma

Summary: the overall objective of the study is to scope the self-management for self-monitoring glaucoma using home tonometry.

monitoring of glaucoma requires frequent evaluation of iop and disease severity, typically with visual field tests. when a patient is diagnosed with glaucoma an optimum level of iop (or target iop) is determined based on patient's characteristics, such as severity of disease and life expectancy. in current models of care patients have their iop measured at the clinic at different intervals. if the iop is noted to be high, or above the patient's target, additional treatment is recommended. accurate and frequent iop measurements at different points in time are thus imperative. tonometry is usually conducted by clinicians in an eye clinic. some tonometers (e.g., icare) have the potential to be used by the individual for home monitoring of iop for patients with suspected glaucoma/glaucoma. self-monitoring of iop via home tonometry will allow patients to undergo iop measurements at different points in time (e.g., early morning and night-time, and it can help determine diurnal changes and spikes). the overall objective of the current study is to conduct a feasibility pilot study on the home tonometer (icare), acquiring initial experience with the icare tonometer. for this purpose investigators will train up to 20 individuals on how to use the device. investigators will ask them to record in a diary their iop twice a day for a period of 2 weeks. investigators will then compare iop outcomes with the measurement taken at the clinic. patients and clinicians will be masked to the iop data.

Eligibility criteria:
inclusion criteria: 1. attending the glaucoma clinic for monitoring (for glaucoma or ocular hypertension) 2. aged 18 years or over 3. patient deemed able to monitor their iop at home (by themselves or a helper) exclusion criteria: 1. not receiving iop monitoring (for glaucoma or ocular hypertension) 2. aged \<18 years 3. patients deemed unable to monitor their iop at home (and do not have someone who can help them) e.g., apparent physical or cognitive impairments that will not allow for the use of a home tonometer 4. had surgery for their glaucoma (glaucoma surgery only; other surgeries included e.g., cataract surgery) 5. patient has preexisting corneal disease
a prospective analysis of biofilm in urinary catheters study

Conditions: Urinary Incontinence

Summary: to analyze biofilm obtained from at least 10 subjects who have an indwelling catheter. a 30cc urine sample would also be collected from the same subject, and analyzed.

after obtaining informed consent, concurrent with the changing of the foley catheter in the clinic, would be obtaining a 30 cc. sample of urine which would also be fast frozen and stored in a -81 degree freezer until shipped to the venter clinic on dry ice.

Eligibility criteria:
inclusion criteria: 1. subject must be 18 years of age. 2. subject is attending weekly office visits at sw wound care center as an out- patient. 3. subject must have an indwelling foley catheter. 4. subject is informed about the trial, understands its nature of the study and provides written informed consent prior to study enrollment. 5. subject is willing and able to comply with all specified care and visit requirements. exclusion criteria: 1. subject refuses to participate in the study. 2. subject is expected to be non-compliant. 3. subject is a resident in a nursing home, or institutionalized. 4. subject is pregnant. 5. subject has a legally authorized representative -

Keywords: standard foley catheter
comparison of treatment success of botox injection in the internal sphincter versus isosorbidedinitrate ointment in patients with an anal fissure

Conditions: Anal Fissure

Summary: the standard treatment of anal fissure in the netherlands (isdn ointment) is being compared to a relatively new treatment (injection of botox in the internal anal sphincter). the study hypothesis is that after 4 months, botox has healed more patients than isdn. the comparison is done blinded for the surgeon and the patient.


Eligibility criteria:
inclusion criteria: * all consecutive patients over the age of 18 with a chronic anal fissure presenting to our surgical outpatient clinic exclusion criteria: * pregnancy * previous anal surgery * crohn's disease * systemic causes of an anal fissure

Keywords: anal fissure fissura ani botox isdn nitric oxide donor
smartphone app and co self-monitoring for smoking cessation

Conditions: Smoking; HIV

Summary: this randomized controlled trial is going to evaluate whether an intervention consisting of a smartphone application to assist smokers living with hiv to quit in combination with co self-monitoring compared to stop smoking counselling by physicians during usual care results in higher self-reported and biochemically verified smoking cessation rates at 6 months. .


Eligibility criteria:
inclusion criteria: hiv-infected smokers ≥ 16 years and smoking ≥ 3 cigarettes /day enrolled into the swiss hiv cohort study willingness to quit smoking speaking one or more of offical swiss national languages or english users of smartphone (specifically iphone 5, 5c, 5s, 6, 6+ running ios version 8.0+; smartphones with resolution of at least 800x400 pixels running, android version 5.0+, and android smartwatches) informed consent exclusion criteria: limitations in hearing, comprehension or vision problems that preclude full study participation participants with a life expectancy of less than 12 months due to any serious medical condition

Keywords: smartphone app co self-monitoring
role of cyp2b6, cyp3a4, and mdr1 in the metabolic clearance of methadone

Conditions: Substance-Related Disorders

Summary: the purpose of this study is to determine to what extent cyp2b6, cyp3a4, and mdr1 polymorphisms affect the metabolism of methadone.

methadone maintenance treatment (mmt) has been used to rehabilitate the opiate addict resulting in a higher quality of life for the patient as well as improving social and psychological functioning while reducing the overall cost to society. the maintenance dose of methadone is highly variable between patients, and drug-drug interactions have been observed between methadone and various medications used to treat a variety of diseases. identification and understanding of the enzymes responsible for the metabolism of methadone could potentially lead to improved strategy in individualizing methadone dosing and reduce the risk of adverse drug interactions. several cytochrome p450 enzymes (cyps) have been identified and hypothesized to be involved in methadone metabolism in vitro, particularly cyp2b6 and cyp3a4. however, the quantitative contribution of cyp2b6 and cyp3a4 in the elimination clearance of methadone in vivo remains undefined. in addition, methadone is a substrate of the efflux transporter, p-glycoprotein (pgp) at the intestinal mucosa. we are proposing a pilot study in healthy human subjects to investigate the following hypotheses: 1. pgp limits the gastrointestinal absorption 2. inter-subject variations in cyp2b6 and cyp3a4 activities explain the variation in methadone clearance in vivo this will be accomplished by correlating the pharmacokinetics of methadone and the phenotype probes for pgp (digoxin), cyp2b6 (bupropion) and cyp3a4 (midazolam). we plan to use these data to design a human subject study to assess the utility of mdr1 and cyp genotyping in predicting the methadone maintenance dose in a cohort of mmt patients.

Eligibility criteria:
inclusion criteria: * healthy * within 25% of ideal body weight exclusion criteria: * pregnant * a prisoner * enemy, non-combatant * smoker * have a history of liver disease * have a history of heart disease * have a history of drug abuse * currently on prescription medication

Keywords: metabolic networks and pathways methadone polymorphism, genetic cytochrome p-450 enzyme system
effect on bleeding when using floseal matrix™ in subjects undergoing endoscopic vein harvest (evh)

Conditions: Bleeding

Summary: this is a prospective, randomized trial to see in patients undergoing coronary artery bypass grafting and endoscopically-harvested greater saphenous vein, if using floseal matrix in the endoscopically-harvested saphenous vein wound bed decreases bleeding and complications.

purpose of study: the primary objective of this study is to determine if using a hemostatic agent (floseal matrix™) in the tunnel of the endoscopically harvested greater saphenous vein will decrease bleeding from that site. secondary objectives are to determine if there is a decrease in the infection-rate at the site of the vein-harvested leg where the floseal matrix™ was used compared to the ones where floseal matrix™ was not used. background and significance: floseal matrix™ is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical. it works on wet, actively bleeding tissue and conforms to irregular wound surfaces. it is proven to control bleeding from oozing to pulsatile flow. the evh wound bed is irregular and hemostasis is, at times, difficult to obtain using conventional procedures such as ligature or cautery. design and procedures: this is a prospective, randomized clinical trial that compares the effects of applying floseal matrix™ to the evh wound bed to not applying floseal matrix™ to the evh wound bed.

Eligibility criteria:
inclusion criteria: 1. sign a consent form that has been approved by the institutional review board. 2. be at least 18 years of age. 3. scheduled to undergo coronary artery bypass grafting with evh. 4. be able to return to duke university medical center for post-operative visit. exclusion criteria: 1. be participating concurrently in another clinical trial that involves an investigational drug or device that would interfere with this study. 2. reported allergy to floseal matrix™

Keywords: endoscopic saphenous vein harvest
bioequivalecne study of minocycline 100mg tablets under fed conditions

Conditions: Healthy

Summary: the purpose of this study was to determine the bioequivalence of minocycline formulations after administration of single doses to normal healthy subjects under fed conditions. these data were to be evaluated statistically to determine if the products meet bioequivalence criteria.

the study was conducted as an open label, balanced, randomised, two-treatment, two-period, two-sequence, single-dose, crossover , bioequivalence study on minocycline comparing minocycline 100mg tablets of ranbaxy with minocin 100mg capsules of in healthy, adult, human, subjects under fed conditions. a total of 24 non-smoking subjects (17 men and 7 women) were included in this study, of which 24 finished the study according to the protocol.

Eligibility criteria:
inclusion criteria: * a) healthy males and females between 18 and 45 years of age inclusive. b) informed of the nature of the study and given written informed consent. c). have a body weight within 15 % of the appropriate range as defined in the 1983 metropolitan life company tables and weighing at least 100 lbs. exclusion criteria: * a) hypersensitivity to minocycline (minocin®), or other antibiotics. b) any history of a clinical condition which might affect drug absorption, metabolism or excretion. c) recent history of mental illness, drug addiction, drug abuse or alcoholism. d) donation of greater than 500 ml of blood in the past 4 weeks prior to study dosing or difficulty in donating blood. e) received an investigational drug within the 4 weeks prior to study dosing. f) currently taking any prescription medication, except oral contraceptives, within the 7 days pr/or to study dosing or over-the-counter medication within 3 days of study dosing. this prohibitior does not include vitamins or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physic/an2 g) tobacco use (\>5 cigarettes per day) in the 3 months prior to study dosing. h) if female, the subject is lactating or has a positive pregnancy test at screening and prior to each of the two treatment periods. females of child bearing potential must use a 'medically acceptable method of contraception throughout the entire study period and for one week after the study is completed. medically acceptable methods of contraception that may be used by the subject and/or her partner are: oral contraceptives, progestin injection' or implants, condom with spermacide, diaphragm with spermacide, iud, vaginal spermicidal suppository, surgical sterilization of their partner(s) or abstinence. females taking oral contraceptives must . have taken them consistently for at least three months prior to receiving study medication.

Keywords: bioequiavlence minocycline tablets
believe study: nesiritide and post myocardial infarction left ventricular modeling

Conditions: Myocardial Infarction

Summary: this study is being done to determine the effects (good and bad) of intravenous infusion of a human brain natriuretic peptide (bnp), natrecor (nesiritide), a hormone produced by the heart in persons who have just suffered a heart attack. the human bnp, natrecor (nesiritide) has been approved by the united states food and drug administration (fda) to be given intravenously for the management of acute heart failure. it is unknown if human bnp may have good effects on the pumping function of the heart after a heart attack.

during the 72 hours of intravenous (iv) nesiritide infusion, if the systolic blood pressure decreases to less than 90 mmhg for 5 minutes, the coronary care unit (ccu) sx will be notified and if the systolic blood pressure has not increased to \> or equal to 90 mmhg within 45 minutes, the nesiritide infusion will be stopped. all patients will receive other medical therapy as determined appropriate by the physician except for angiotensin converting enzyme inhibitor (acei), which will be started 24 hours after iv nesiritide. lisinopril will be started 24 hours after the start of iv nesiritide at an initial dose of 2.5 mg and to be titrated up by the participants' physician according to their clinical status. the window for the lisinopril doses would be +/- 1 hour. patients with any signs or symptoms of post revascularization ischemia will be discontinued from the study. blood for the measurement of renin, angiotensin ii (ang ii), aldosterone (aldo), endothelin (et)-1, norepinephrine, atrial natriuretic peptide (anp), brain natriuretic peptide (bnp), cgmp, c reactive protein, tumor necrosis factor (tnf)-alpha, matrix metalloproteinase (mmp)-2 and tissue inhibitor of metalloproteinase (timp)-2 will be drawn before the initiation of iv nesiritide, six hours into the infusion before the initiation of acei and just before completion of the 72 hour infusion. the window for the blood draw for the six hour time point would be +/- 1 hour and the 72 hour time point would be +/-1 hour or just prior to discharge but not less than 66 hours. muga will be performed within 24 hours after the initiation of the iv nesiritide to assess systolic and diastolic volumes and lv ejection fraction (ef). follow up at 4 weeks: all patients, whether they complete the entire 72 hours of the nesiritide infusion or not, will return 1 month later for a repeat muga and blood draw for the neurohumoral profiling and pregnancy test if required by nuclear cardiology. the visit window for the one month return would be 30 to 40 days.

Eligibility criteria:
inclusion criteria: * patients with acute st elevation myocardial infarction of at least \> 2mv st elevation in two or more anterior precordial leads, with successful revascularization (thrombolysis in myocardial infarction \[timi\] grade 3 flow) of the lesion within 24 hours of chest pain as documented by coronary angiogram.
liquid biopsy to reduce time to treatment for advanced nonsquamous nsclc diagnosed at outside sites

Conditions: Non Small Cell Lung Cancer

Summary: the purpose of this study is to determine if liquid biopsies will reduce time to begin treatment in participants with non-small cell lung cancer (nsclc). a liquid biopsy is a test done on a sample of blood to look for cancer cells.

referred patients with newly diagnosed nsclc who have not had genetic testing for targetable mutations will be considered for this study. the primary objective of this prospective study is to examine if using liquid biopsy can reduce time to treatment (ttt) in external participants with nsclc. secondary objectives examined will include time to actionable genetic testing results (ctdna or tissue), rate of actionable biomarker discovery, and rate of appropriate guideline-directed therapy based upon testing results. a liquid biopsy is a test done on a sample of blood to look for cancer cells. a traditional biopsy, which requires tissue to be removed from the body, takes 14 days to be tested. a liquid biopsy takes 7 days which significantly shortens the ttt for those diagnosed with nsclc. by studying this, doctors may be better able to determine if this will be beneficial and result in less time taken to treat cancer.

Eligibility criteria:
inclusion criteria: * participants with newly diagnosed, advanced nonsquamous nsclc referred to the cleveland clinic taussig cancer center from outside centers without prior testing results available for targetable genetic alterations * plan to receive systemic therapy at the cleveland clinic, or plan to receive systemic therapy at an outside site while maintaining either intermittent follow up at cleveland clinic or with electronic health record access through care everywhere. exclusion criteria: * prior therapy for this diagnosis of nsclc * prior adequate molecular testing done for the current diagnosis of nsclc
characteristics predictive of pessary success

Conditions: All Patients Who Have Undergone a Pessary Fitting

Summary: pessaries are mechanical support devices worn vaginally to treat the symptoms of pelvic organ prolapse, such as vaginal pressure or a vaginal bulge. pessaries are one of the options along with surgery and expectant management for pelvic organ prolapse. as the aging population grows, more patients will need treatment for pelvic organ prolapse. various studies have been conducted previously to identify patient parameters predictive of successful pessary fitting and continued use. our study is a retrospective chart review to identify patient characteristics predictive of successful pessary fitting and use, specifically focusing on the parameters of popq, pelvic organ prolapse quantification exam, and the ratio of the genital hiatus, which is the length of the vaginal opening, and total vaginal length.


Eligibility criteria:
inclusion criteria: * undergone a pessary fitting by physicians in the division of urogynecology between the years of 2000 to 20008. exclusion criteria: * patients will be excluded only if their chart does not contain the clinical data under review.

Keywords: pelvic organ prolapse pessary fitting